The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Raffaele De Caterina; Giancarlo Agnelli; Petra Laeis; Martin Unverdorben; Heiko Rauer; Chun Chieh Wang; Mashio Nakamura; Kuan Ming Chiu; Paul Egbert Reimitz; Yukihiro Koretsune; Cathy Chen; Ulrike Thee; Jumpei Kaburagi; Young Hoon Kim; Won Il Choi; Takeshi Yamashita; Alexander Cohen; Paulus Kirchhof

doi:10.1002/clc.23279

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Raffaele De Caterina, Giancarlo Agnelli, Petra Laeis, Martin Unverdorben, Heiko Rauer, Chun Chieh Wang, Mashio Nakamura, Kuan Ming Chiu, Paul Egbert Reimitz, Yukihiro Koretsune, Cathy Chen, Ulrike Thee, Jumpei Kaburagi, Young Hoon Kim, Won Il Choi, Takeshi Yamashita, Alexander Cohen, Paulus Kirchhof

Research output: Contribution to journal › Article › peer-review

17 Citations (Scopus)

Abstract

Background: Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods: The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication-specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow-up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results: Globally, enrollment began in early 2015 and is ongoing. Conclusions: Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.

Original language	English
Pages (from-to)	1147-1154
Number of pages	8
Journal	Clinical Cardiology
Volume	42
Issue number	12
DOIs	https://doi.org/10.1002/clc.23279
Publication status	Published - 2019 Dec 1

Bibliographical note

Funding Information:
RDC reports being a coauthor for ESC Guidelines on Atrial Fibrillation 2010–2012; steering committee member, National Coordinator for Italy; coauthor of APPRAISE‐2, ARISTOTLE, AVERROES, ENGAGE AF‐TIMI 48, Re‐DUAL PCI; and fees, honoraria, and research funding from Sanofi‐Aventis, Boehringer Ingelheim, Bayer, Pfizer, Bristol‐Myers Squibb, Daiichi Sankyo, Novartis, Merck, and Portola. GA reports consultant or speaker fees from Bayer, BMS‐Pfizer, and Daiichi‐Sankyo. CCW reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, and Daiichi Sankyo. MN reports personal fees from Daiichi Sankyo during the conduct of the study; personal fees from Bayer Yakuhin, Ltd., Pfizer Japan Inc., and Bristol‐Myers Squibb K.K. outside the submitted work. KMC reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, Pfizer and Daiichi Sankyo. YK reports being a coauthor for JCS Guidelines on Atrial Fibrillation 2013; coauthor of ENGAGE AF‐TIMI 48; lecture fees from Daiichi Sankyo, Boehringer Ingelheim, Pfizer, Bayer HealthCare, and Bristol‐Myers Squibb; and grant support through his institution from Daiichi Sankyo and Boehringer Ingelheim. YHK is a member of the advisory committee for the ETNA‐AF study, and received honoraria (lecture fees), consulting fees, and research grants from Daiichi Sankyo. TY reports research funding from Bristol‐Myers Squibb, Bayer HealthCare, Daiichi Sankyo, and Mitsubishi‐Tanabe Pharmaceutical; and remuneration from Daiichi Sankyo, Bayer HealthCare, Pfizer, Bristol‐Myers Squibb, Boehringer Ingelheim, Eisai, Toa Eiyo, Takeda, and Ono Pharmaceutical. AC receives consulting fees from AbbVie, ACI Clinical, Aspen, Bayer, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Boston Scientific, CSL Behring, Daiichi‐Sankyo, GlaxoSmithKline, GLG, Guidepoint Global, Johnson and Johnson, Leo Pharma, Medscape, McKinsey, Navigant, ONO, Pfizer, Portola, Sanofi, Temasek Capital, and TRN. WIC and PK report no conflicts of interest. PL, MU, HR, PR, CC, UT, and JK are employees of Daiichi Sankyo.

Funding Information:
Funding for ETNA was provided by Daiichi Sankyo, Inc. Medical writing assistance was provided by Kathleen Pieper, PhD; and Stefan Kolata, PhD, of AlphaBioCom (King of Prussia, PA) and funded by Daiichi Sankyo, Inc.

Publisher Copyright:
© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1002/clc.23279

Cite this

De Caterina, R., Agnelli, G., Laeis, P., Unverdorben, M., Rauer, H., Wang, C. C., Nakamura, M., Chiu, K. M., Reimitz, P. E., Koretsune, Y., Chen, C., Thee, U., Kaburagi, J., Kim, Y. H., Choi, W. I., Yamashita, T., Cohen, A., & Kirchhof, P. (2019). The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design. Clinical Cardiology, 42(12), 1147-1154. https://doi.org/10.1002/clc.23279

De Caterina, R, Agnelli, G, Laeis, P, Unverdorben, M, Rauer, H, Wang, CC, Nakamura, M, Chiu, KM, Reimitz, PE, Koretsune, Y, Chen, C, Thee, U, Kaburagi, J, Kim, YH, Choi, WI, Yamashita, T, Cohen, A & Kirchhof, P 2019, 'The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design', Clinical Cardiology, vol. 42, no. 12, pp. 1147-1154. https://doi.org/10.1002/clc.23279

@article{4da02e28b188425f8bfe2b5979d686f8,

title = "The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design",

abstract = "Background: Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods: The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication-specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow-up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results: Globally, enrollment began in early 2015 and is ongoing. Conclusions: Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.",

author = "{De Caterina}, Raffaele and Giancarlo Agnelli and Petra Laeis and Martin Unverdorben and Heiko Rauer and Wang, {Chun Chieh} and Mashio Nakamura and Chiu, {Kuan Ming} and Reimitz, {Paul Egbert} and Yukihiro Koretsune and Cathy Chen and Ulrike Thee and Jumpei Kaburagi and Kim, {Young Hoon} and Choi, {Won Il} and Takeshi Yamashita and Alexander Cohen and Paulus Kirchhof",

note = "Funding Information: RDC reports being a coauthor for ESC Guidelines on Atrial Fibrillation 2010–2012; steering committee member, National Coordinator for Italy; coauthor of APPRAISE‐2, ARISTOTLE, AVERROES, ENGAGE AF‐TIMI 48, Re‐DUAL PCI; and fees, honoraria, and research funding from Sanofi‐Aventis, Boehringer Ingelheim, Bayer, Pfizer, Bristol‐Myers Squibb, Daiichi Sankyo, Novartis, Merck, and Portola. GA reports consultant or speaker fees from Bayer, BMS‐Pfizer, and Daiichi‐Sankyo. CCW reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, and Daiichi Sankyo. MN reports personal fees from Daiichi Sankyo during the conduct of the study; personal fees from Bayer Yakuhin, Ltd., Pfizer Japan Inc., and Bristol‐Myers Squibb K.K. outside the submitted work. KMC reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, Pfizer and Daiichi Sankyo. YK reports being a coauthor for JCS Guidelines on Atrial Fibrillation 2013; coauthor of ENGAGE AF‐TIMI 48; lecture fees from Daiichi Sankyo, Boehringer Ingelheim, Pfizer, Bayer HealthCare, and Bristol‐Myers Squibb; and grant support through his institution from Daiichi Sankyo and Boehringer Ingelheim. YHK is a member of the advisory committee for the ETNA‐AF study, and received honoraria (lecture fees), consulting fees, and research grants from Daiichi Sankyo. TY reports research funding from Bristol‐Myers Squibb, Bayer HealthCare, Daiichi Sankyo, and Mitsubishi‐Tanabe Pharmaceutical; and remuneration from Daiichi Sankyo, Bayer HealthCare, Pfizer, Bristol‐Myers Squibb, Boehringer Ingelheim, Eisai, Toa Eiyo, Takeda, and Ono Pharmaceutical. AC receives consulting fees from AbbVie, ACI Clinical, Aspen, Bayer, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Boston Scientific, CSL Behring, Daiichi‐Sankyo, GlaxoSmithKline, GLG, Guidepoint Global, Johnson and Johnson, Leo Pharma, Medscape, McKinsey, Navigant, ONO, Pfizer, Portola, Sanofi, Temasek Capital, and TRN. WIC and PK report no conflicts of interest. PL, MU, HR, PR, CC, UT, and JK are employees of Daiichi Sankyo. Funding Information: Funding for ETNA was provided by Daiichi Sankyo, Inc. Medical writing assistance was provided by Kathleen Pieper, PhD; and Stefan Kolata, PhD, of AlphaBioCom (King of Prussia, PA) and funded by Daiichi Sankyo, Inc. Publisher Copyright: {\textcopyright} 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.",

year = "2019",

month = dec,

day = "1",

doi = "10.1002/clc.23279",

language = "English",

volume = "42",

pages = "1147--1154",

journal = "Clinical Cardiology",

issn = "0160-9289",

publisher = "John Wiley and Sons Inc.",

number = "12",

}

TY - JOUR

T1 - The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program

T2 - rationale and design

AU - De Caterina, Raffaele

AU - Agnelli, Giancarlo

AU - Laeis, Petra

AU - Unverdorben, Martin

AU - Rauer, Heiko

AU - Wang, Chun Chieh

AU - Nakamura, Mashio

AU - Chiu, Kuan Ming

AU - Reimitz, Paul Egbert

AU - Koretsune, Yukihiro

AU - Chen, Cathy

AU - Thee, Ulrike

AU - Kaburagi, Jumpei

AU - Kim, Young Hoon

AU - Choi, Won Il

AU - Yamashita, Takeshi

AU - Cohen, Alexander

AU - Kirchhof, Paulus

N1 - Funding Information: RDC reports being a coauthor for ESC Guidelines on Atrial Fibrillation 2010–2012; steering committee member, National Coordinator for Italy; coauthor of APPRAISE‐2, ARISTOTLE, AVERROES, ENGAGE AF‐TIMI 48, Re‐DUAL PCI; and fees, honoraria, and research funding from Sanofi‐Aventis, Boehringer Ingelheim, Bayer, Pfizer, Bristol‐Myers Squibb, Daiichi Sankyo, Novartis, Merck, and Portola. GA reports consultant or speaker fees from Bayer, BMS‐Pfizer, and Daiichi‐Sankyo. CCW reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, and Daiichi Sankyo. MN reports personal fees from Daiichi Sankyo during the conduct of the study; personal fees from Bayer Yakuhin, Ltd., Pfizer Japan Inc., and Bristol‐Myers Squibb K.K. outside the submitted work. KMC reports consulting fees and honoraria from Bayer, Boehringer Ingelheim, Pfizer and Daiichi Sankyo. YK reports being a coauthor for JCS Guidelines on Atrial Fibrillation 2013; coauthor of ENGAGE AF‐TIMI 48; lecture fees from Daiichi Sankyo, Boehringer Ingelheim, Pfizer, Bayer HealthCare, and Bristol‐Myers Squibb; and grant support through his institution from Daiichi Sankyo and Boehringer Ingelheim. YHK is a member of the advisory committee for the ETNA‐AF study, and received honoraria (lecture fees), consulting fees, and research grants from Daiichi Sankyo. TY reports research funding from Bristol‐Myers Squibb, Bayer HealthCare, Daiichi Sankyo, and Mitsubishi‐Tanabe Pharmaceutical; and remuneration from Daiichi Sankyo, Bayer HealthCare, Pfizer, Bristol‐Myers Squibb, Boehringer Ingelheim, Eisai, Toa Eiyo, Takeda, and Ono Pharmaceutical. AC receives consulting fees from AbbVie, ACI Clinical, Aspen, Bayer, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Boston Scientific, CSL Behring, Daiichi‐Sankyo, GlaxoSmithKline, GLG, Guidepoint Global, Johnson and Johnson, Leo Pharma, Medscape, McKinsey, Navigant, ONO, Pfizer, Portola, Sanofi, Temasek Capital, and TRN. WIC and PK report no conflicts of interest. PL, MU, HR, PR, CC, UT, and JK are employees of Daiichi Sankyo. Funding Information: Funding for ETNA was provided by Daiichi Sankyo, Inc. Medical writing assistance was provided by Kathleen Pieper, PhD; and Stefan Kolata, PhD, of AlphaBioCom (King of Prussia, PA) and funded by Daiichi Sankyo, Inc. Publisher Copyright: © 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

PY - 2019/12/1

Y1 - 2019/12/1

N2 - Background: Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods: The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication-specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow-up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results: Globally, enrollment began in early 2015 and is ongoing. Conclusions: Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.

AB - Background: Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods: The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication-specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow-up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results: Globally, enrollment began in early 2015 and is ongoing. Conclusions: Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.

UR - http://www.scopus.com/inward/record.url?scp=85074617620&partnerID=8YFLogxK

U2 - 10.1002/clc.23279

DO - 10.1002/clc.23279

M3 - Article

C2 - 31650560

AN - SCOPUS:85074617620

SN - 0160-9289

VL - 42

SP - 1147

EP - 1154

JO - Clinical Cardiology

JF - Clinical Cardiology

IS - 12

ER -

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Abstract

Bibliographical note

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this